A glossary of words associated with Quality systems and Statistics.

Accreditation: Certification by a duly recognized body of the facilities, capability, objectivity, competence, and integrity of an agency, service or operational group or individual to provide the specific service(s) or operation(s) needed.

Accredited Registrars: Qualified organizations certified by a national body (e.g., the Registrar Accreditation Board in the USA) to perform audits to the QS-9000 and to register the audited facility as meeting these requirements for a given commodity.

Accuracy: Closeness of agreement between the result of a measurement and the (conventional) true value of the measurement.

Aliquot: A measured sub-volume of sample.ANSI: American National Standards Institute.

AQL: Acceptable quality level.

AS9100: Quality system requirements for suppliers to the aerospace industry (previously known as AS9000).

ASQ: American Society for Quality.

Assessment: An evaluation process including a document review, an on-site audit and an analysis and report. (see Quality audit)  

Assignable cause: See Special cause.

ASTM: American Society for Testing and Materials.  

Attributes: Qualitative data that can be counted for recording and analysis. Examples include characteristics such as the presence of a required label and the installation of all required fasteners.  

Audit: An onsite verification activity used to determine the effective implementation of a supplier's documented quality system.

Audit: Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Audit client: Organization or person requesting an audit.

Audit conclusion: Outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings.

Audit criteria: Set of policies, procedures or requirements used as a reference (while conducting an audit).

Auditee: Organization being audited.

Audit evidence: Records, statements of fact or other information which are relevant to the audit criteria and verifiable.

Audit findings: Results of the evaluation of the collected audit evidence against audit criteria.

Auditor: Person with the competence to conduct an audit.

Audit program: Set of one or more audits planned for a specific time frame and directed towards a specific purpose.

Audit team: One or more auditors conducting an audit.

Availability: he ability of an item to perform its designated function when required for use.  

Average or mean: The most common expression of the centering of a distribution. It is calculated by totaling the observed values and dividing by the number of observations.

Benchmark Data: The results of an investigation to determine how competitors and/or best-in-class companies achieve their level of performance.

Bimodal Distribution: A distribution with two identifiable curves within it, indicating a mixing of two populations such as different shifts, machines, workers, etc.

BS: British Standard.

BSI: British Standards Institution.

CAI: Computer aided inspection.

Capability: The total range of inherent variation in a stable process. (See Process Capability)

Capability: Ability of an organization, system or process to realize a product that will fulfill the requirements for that product.

CASCO: ISO Committee on Conformity Assessments.

CC: ritical characteristic.

CE Mark: European Union product safety certification symbol.

CEN: European Committee for Standardization.

Certificate of compliance: A document signed by an authorized party affirming that the supplier of a product or service has met the requirements of the relevant specifications, contract, or regulation.

Certificate of conformance (Certificate of conformity): A document signed by an authorized party affirming that a product or service has met the requirements of the relevant specifications, contract, or regulation.

Certification: The procedure and action by a duly authorized body of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with applicable requirements.

Characteristic: Distinguishing feature.

CIM: Computer Integrated Manufacturing.

Cause: A source of variation that is always present as part of the random variation inherent in the process itself. Its origin can usually be traced to an element of the system which only Common management can correct.

Competence: Demonstrated ability to apply knowledge skills.

Compliance: An affirmative indication or judgment that the supplier of a product or service has met the requirements of the relevant specifications, contract, or regulation; also the state of meeting the requirements.

Component: Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

Concentration factor: Ratio of Aliquot volume divided by the Final volume.

Concession: Permission to use or release a product that does not conform to specified requirements.

Conformance: An affirmative indication or judgment that a product or service has met the requirements of the relevant specifications, contract, or regulation; also the state of meeting the requirements.

Conformity: The fulfilling by an item or service of specification requirements.  

Conformity: Fulfillment of a requirement.

Continual improvement: Recurring activity to increase the ability to fulfill requirements.

Control Chart: A graphic representation of a characteristic of a process, showing plotted values of some statistic gathered from that characteristic, and one or two control limits.

Control Limit: A line (or lines) on a control chart used as a basis for judging the significance of the variation from subgroup to subgroup. Variation beyond a control limit is evidence that special causes are affecting the process. Control limits are calculated from process data and are not to be confused with engineering specifications.

Control Plans: Written descriptions of the systems for controlling parts and processes.

Correction: Action to eliminate a detected nonconformity.

Corrective action: Action to eliminate the cause of a detected nonconformity or other undesirable situation.

Corrective Action Plan: A plan for correcting a process or part quality issue.

CQA: Certified Quality Auditor.

CQE: Certified Quality Engineer.

CQMgr: Certified Quality Manager.

CRE: Certified Reliability Engineer.

Customer: Organization or person that receives a product.

Customer satisfaction: Customer's perception of the degree to which the customer's requirements have been fulfilled. Defect: Non-fulfillment of a requirement related to an intended or specified use.

Dependability: Collective term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance and maintenance support performance.

Design and development: Set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system.

Design Failure Mode and Effects Analysis (DFMEA): An analytical technique used by a design responsible engineer/team as a means to assure, to the extent possible, that potential failure modes and, their associated causes/mechanisms have been considered and addressed.  

Design for Manufacturability and Assembly: A simultaneous engineering process designed to optimize the relationship between design function, manufacturability, and ease of assembly.

Design input: The physical and performance requirements of a device that are used as a basis for device design.

Design Review: A proactive process to prevent problems and misunderstandings.

Design Review: A formal, documented, comprehensive, and systematic examination of a design to evaluate the design requirements and the capability of the design to meet these requirements and to identify problems and propose solutions.

Design review: A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

Design Validation: Testing to ensure that product conforms to defined user needs and/or requirements. Design validation follows successful design verification and is normally performed on the final product under defined operating conditions. Multiple validations may be performed if there are different intended uses.

Design Validation: Establishing by objective evidence that device specifications conform with user needs and intended use(s).

Design Verification: Testing to ensure that all design outputs meet design input requirements. Design verification may include activities such as: • Design review; • Performing alternate calculations; • Understanding tests and demonstrations; • Review of design stage documents before release.

Detection or inspection: A past-oriented strategy that attempts to identify unacceptable output after it has been produced and separate it from the good output. (See Prevention and Nonconforming)

Deviation permit: Written authorization, prior to production or provision of a service, to depart from specified requirements for a specified quantity or for a specified time.

Deviation permit: Permission to depart from the originally specified requirements of a product prior to realization.

DFA: Design for assembly.

DFM: Design for manufacturing.

DFMEA: Design Failure Mode and Effects Analysis.

Diluent: Material into which a sample is added to be diluted.

Dilution factor: Ratio of (Aliquot volume + Diluent volume) divided by Aliquot volume.

DIN: Germany Standards Institute.

Distribution: The population (universe) from which observations are drawn, categorised into cells, and form identifiable patterns. It is based on the concept of variation that states that anything measured repeatedly will arrive at different results. These results will fall into statistically predictable patterns. A bell-shaped curve (normal distribution) is an example of a distribution in which the greatest number of observations occur in the center, with fewer and fewer observations falling evenly on either side of the average. Document: Information and its supporting medium.

Documentation: Written material defining the process to be followed (e.g. test procedure, quality manual, operation sheets).

DOE: Design of Experiments.

Durability: The probability that an item will continue to function at customer expectation levels, at the useful life without requiring overhaul or rebuild due to wearout.

EN: European Standard.

Establish: Define, document (in writing or electronically), and implement.

Efficacy: (see Effectiveness below)

Efficiency: Relationship between the result achieved and the resources used.

Effectiveness: Extent to which planned activities are realized and planned results achieved.

FMEA method (FMECA): Failure Mode and Effect (and Criticality) Analysis, a powerful method of risk assessment and failure analysis for use in risk management and product liability control.

Frequency distribution: A statistical table that presents a large volume of data in such a way that the central tendency (average/mean/median) and distribution are clearly displayed.

FTA: Fault Tree Analysis.

Functional Verification: Testing to ensure the part conforms to all customer and supplier engineering performance and material requirements.

Generally implied: Custom or common practice for the organization, its customers and other interested parties, that the need or expectation under consideration is implied.

GD&T: Geometric Dimensioning and Tolerancing. GMP: Good Manufacturing Practice.

GR&R: Gage Repeatability and Reproducibility.

Grade: An indicator of category or rank related to features or characteristics that cover different sets of needs for products or services intended for the same functional use. Hardware: Tangible, discrete product with distinctive form.  

Histogram: See Frequency distribution.

Information: Meaningful data.

Infrastructure (of an organization): System of facilities, equipment and services needed for the operation of an organization.

Inspection: Activities, such as measuring, examining, testing, gaging one or more characteristics of a product or service, and comparing these with specified requirements to determine conformity.  

Inspection: Conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing or gauging.  

Interested party: Person or group having an interest in the performance or success of an organization.

ISO: International Organization for Standards.

Kaizen: Taken from the Japanese words kai and zen, where kai means change and zen means good. The popular meaning is continual improvement of all areas of a company not just quality.

LCL: Lower control limit. (see Control limit)

LOD: Limit of Detection. At low concentrations, an increasing variety of effects becomes important, including, for example, noise due to measurement, unstable baseline, interfering substances, influence of analytical blank, and losses during extraction, isolation or clean-up. Because of such effects, as analyte concentrations drop, the relative uncertainty associated with the result tends to increase, first to a substantial fraction of the result and finally to the point where the (symmetric) uncertainty interval includes zero. The Limit of Detection is the level below which the test can no longer accurately measure the amount of a substance.

LOQ: Limit of Quantification. Lowest concentration of an analyte in a defined matrix where positive identification and quantitative measurement can be achieved using a specified method. LOQ has been defined as 3 times the LOD or as 50% above the lowest level used to validate the method.

LOR: Limit of Reporting. Practical limit of analyte quantitation at or above the LOQ. The limit of quantitation for a defined matrix and method may vary between laboratories or within the one laboratory from time to time because of different equipment, techniques and reagents.

Lot or batch: One or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. LSL: Lower specification limit. (see Specification)

Maintainability: Ability of an item under stated conditions of use to be retained in, or restored to, within a given period of time, a specified state in which it can perform its required functions when maintenance is performed under stated conditions and while using prescribed procedures and resources.

Management: Coordinated activities to direct and control an organization.

Management system: System to establish policy and objectives and to achieve those objectives.

Measurement control system: Set of interrelated or interacting elements necessary to achieve metrological confirmation and continual control of measurement processes.

Measurement process: Set of operations to determine the value of a quantity.

Measuring equipment: Measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process.

Metrological characteristic: Distinguishing feature which can influence the results of measurement.

Metrological confirmation: Set of operations required to ensure that measuring equipment conforms to the requirements for its intended use.

Metrological function: Function with organizational responsibility for defining and implementing the measurement control system.

MSA: Measurement System Analysis.

MTBF: Mean time between failures.

NDT: Nondestructive testing.

NIST: National Institute of Science and Technology.

Nonconformance: Product or material which does not conform to the customer requirements or specifications.

Nonconformities: Specific occurrences of a condition that does not conform to specifications or other inspection standards; sometimes called discrepancies or defects

Nonconformity: The non-fulfillment of specified requirements. A process which does not conform to a quality system requirement.

Normal Distribution: See Distribution.

Numerical reliability: The probability that an item will perform a required function under stated conditions for a stated period of time. (See MTBF)

Objective evidence: Data supporting the existence or verity of something.

Organization: Group of people and facilities with an arrangement of responsibilities, authorities and relationships.

Organizational structure: Arrangement of responsibilities, authorities and relationships between people.

Parts Per Million (PPM): PPM is a way of stating the performance of a process in terms of actual or projected defective material.

PFMEA: Process Failure Mode and Effects Analysis.

Population: The universe of data under investigation from which a sample will be taken.  

Prevention: A future-oriented strategy that improves quality by directing analysis and action toward correcting the production process. Prevention is consistent with a philosophy of never-ending improvement.

Preventive action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.

Procedure: Specified way to carry out an activity or a process.

Process: The combination of people, machine and equipment, raw materials, methods, and environment that produces a given product or service. Process: Set of interrelated or interacting activities which transforms inputs into outputs.

Process Capability: The measured, built-in reproducibility (consistency) of the product turned out by the process. Such a determination is made using statistical methods, not wishful thinking. The statistically determined pattern or distribution can only then be compared to specification limits to decide if a process can consistently deliver product within those parameters.

Process Failure Mode and Effects Analysis (PFMEA): An analytical technique used by a manufacturing responsible engineer/team as a means to assure that, to the extent possible, potential failure modes and their associated causes/mechanisms have been considered and addressed.

Process quality audit: An analysis of elements of a process and appraisal of completeness, correctness of conditions, and probable effectiveness.  

Process validation: Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Product: Result of a process. May be services, software, hardware or processed materials, or a combination thereof.

Product liability or Service liability: A generic term used to describe the onus on a producer or others to make restitution for loss related to personal injury, property damage, or other harm caused by a product or service.

Product quality audit: A quantitative assessment of conformance to required product characteristics.

Project: Unique process, consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources.

QFD: Quality Function Deployment (see QFD FAQ)

QMS: Quality Management System (see Quality system)

QS-9000: Quality system requirements for suppliers to Daimler Chrysler, Ford and General Motors.

QSR: Quality System Requirements.

Qualification process: Process to demonstrate the ability to fulfill specified requirements.

Quality: The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.  

Quality: The totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.

Quality: Degree to which a set of inherent (existing) characteristics fulfils requirements.

Quality assurance: All those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.

Quality assurance: Part of quality management focused on providing confidence that quality requirements will be fulfilled.

Quality audit (also quality assessment, or conformity assessment): A systematic and independent examination and evaluation to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. (see Quality system audit)

Quality characteristic: Inherent characteristic of a product, process or system related to a requirement.

Quality control: The operational techniques and the activities used to fulfill requirements of quality.  

Quality engineering: That branch of engineering which deals with the principles and practice of product and service quality assurance and control.

Quality improvement: Part of quality management focused on increasing the ability to fulfill quality requirements.

Quality loop; Conceptual model of interacting activities that influence the quality of a product or service in the various stages ranging from the identification of needs to the assessment of whether these needs have been satisfied.

Quality management: Coordinated activities to direct and control an organization with regard to quality.

Quality management system: Management system to direct and control an organization with regard to quality.  

Quality manual: Document specifying the quality management system of an organization.

Quality measure: A quantitative measure of the features and characteristics of a product or service.

Quality objective: Something sought, or aimed for, related to quality.

Quality Plan: A document setting out the specific quality practices, resources, and activities relevant to a particular product, process, service, contract, or project.

Quality plan audit: See Quality system audit

Quality Planning: A structured process for defining the methods (i.e., measurements, tests) that will be used in the production of a specific product or family of products (i.e., parts, materials). (See Quality Plan)

Quality planning: Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives.

Quality policy: The overall intentions and direction of an organization as regards quality as formally expressed by top management.  

Quality policy: Overall intentions and direction of an organization related to quality as formally expressed by top management.

Quality surveillance: The continuing monitoring and verification of the status of procedures, methods, conditions, products, processes, and services, and analysis of records in relation to stated references to ensure that requirements for quality are being met.

Quality system: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

Quality system audit: A documented activity performed to verify, by examination and evaluation of objective evidence, that applicable elements of the quality system are suitable and have been developed, documented, and effectively implemented in accordance with specified requirements.

Quality system review: A formal evaluation by management of the status and adequacy of the quality system in relation to quality policy and/or new objectives resulting from changing circumstances.

Range: A measure of the variation in a set of data. It is calculated by subtracting the lowest value in the data set from the highest value in that same set.

Reaction Plan: The action specified by a Control Plan when nonconforming product or process instability is identified.

Realization (as used in ISO 9000:2000): The carrying out of an action or process to completion.

Record: Document stating results achieved or providing evidence of activities performed.

Registrar: A company that conducts quality system assessments to the Quality System Requirements.  

Regrade: Alteration of the grade of a nonconforming product in order to make it conform to requirements differing from the original ones.  

Relative quality: Degree of excellence of a product or service.

Release: Permission to proceed to the next stage of a process.

Reliability: The probability that an item will continue to function at customer expectation levels at a measurement point, under specified environmental and duty cycle conditions.

Reliability engineering: That engineering function dealing with the principles and practices related to the design, specification, assessment, and achievement of product or system reliability requirements and involving aspects of prediction, evaluation, production, and demonstration.  

Repair: Action on a nonconforming product to make it acceptable for the intended use.

Requirement: Need or expectation that is stated, generally implied or obligatory.

Review: Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives.

Rework: Action taken on a nonconforming product so that it will fulfill the specified requirements before it is released for distribution.  

Runs: The patterns in a Control Chart within which a number of points line up on only one side of the central line.

Sample: One or more individual events or measurements selected from the output of a process for purposes of identifying characteristics and performance of the whole.

Scrap: Action on a nonconforming product to preclude its originally intended use.

Sigma (σ): The Greek letter used to designate the estimated standard deviation.

Simulation: The practice of mimicking some or all of the behavior of one system with a different, dissimilar system.

Simultaneous Engineering: A way of simultaneously designing products, and the processes for manufacturing those products, through the use of cross-functional teams to assure manufacturability and to reduce cycle time.

Six Sigma: Quality process, developed at Motorola, focused on reducing defects to a six sigma level (3.4 defects per million parts; 0.00034%), for all practical purposes zero defects.

SMWT: Self-managed work teams. SPC: Statistical Process Control. (see below)

Special Cause: A source of variation that is intermittent, unpredictable, unstable; sometimes called an assignable cause.

Specification: The document that prescribes the requirements with which the product or service has to conform.

SQC: Statistical Quality Control. (see below)

Stakeholder: An individual or group of individuals with a common interest in the performance of the supplier organization and the environment in which it operates.

Standard Deviation: A measure of the spread of the process output or the spread of a sampling statistic from the process (e.g., of subgroup averages), denoted by the Greek letter (sigma) for the estimated standard deviation. See Sigma

Statistical Control: The condition describing a process from which all special causes have been removed, evidenced on a control chart by the absence of points beyond the control limits and by the absence of non-random patterns or trends within the control limits.

Statistical Process Control: The use of statistical techniques such as Control Charts to analyze a process or its output to take appropriate actions to achieve and maintain a state of statistical control and to improve the capability of the process.

Statistical Quality Control: The application of statistical techniques to the control of quality.

Stratification: The process of classifying data into subgroups based on characteristics or categories.

Supplier: Organization or person that provides a product. System: Set of interrelated or interacting elements.

Technical expert (in an audit): Person who provides specific knowledge of or expertise on the subject to be audited.

Test: Determination of one or more characteristics according to a procedure.

Testing: A means of determining the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating actions and conditions.  

Top management: Person or group of people who directs and controls an organization at the highest level.

TPM: Total productive maintenance TQM: Total quality management.

Traceability: The ability to trace the history, application, or location of an item or activity and like items or activities by means of recorded identification.

UCL: Upper control limit (see Control limit) USL: Upper specification limit (see Specification)

Validation: Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.  

Variables: Those characteristics of a part that can be measured. Examples are length in millimeters, resistance in ohms, closing effort of a door in kilograms, and the torque of a nut in foot pounds. (See Attributes)

Variation: The inevitable difference among individual outputs of a process. The sources of variation can be grouped into two major classes: Common Causes and Special Causes.

Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.

Voice of the Customer: Customer feedback both positive and negative; including likes, dislikes, problems and suggestions.

Voice of the Process: Statistical data that is feedback to the people in the process to make decisions about the process stability and/or capability as a tool for continual improvement. See Statistical Process Control)

Waiver: Written authorization to use or release a quantity of material, components, or stores already manufactured but not conforming to the specified requirements.

Work environment: Set of conditions under which work is performed.

 

Zero Defects: The quality concept of zero tolerance for defects. (see Six Sigma) 

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